Acor­da gets a bad­ly need­ed PDU­FA date with the FDA on Parkin­son's drug; Take­da signs neu­ro­log­i­cal col­lab­o­ra­tion with an­ti­sense play­er Wave Life Sci­ences

Acor­da $ACOR says that the FDA has fi­nal­ly ac­cept­ed their ap­pli­ca­tion for In­bri­ja (CVT-301), putting their in­haled form of lev­odopa for Parkin­son’s on track for a mar­ket­ing de­ci­sion by Oc­to­ber 5. The reg­u­la­to­ry ad­vance comes 6 months af­ter the agency ini­tial­ly re­fused to file their ap­pli­ca­tion, which now leaves the FDA due to make a de­ci­sion by Oc­to­ber. That’s a big deal at Acor­da, as its last re­main­ing patent pro­tect­ing its big drug Ampyra is set to ex­pire this sum­mer, leav­ing them stripped of any le­gal ar­mor against the gener­ics that will shred that mar­ket. Acor­da re­lies on Ampyra for al­most all of its rev­enue.

Take­da has beefed up its neu­ro­science di­vi­sion with a four-year, mul­ti-pro­gram op­tion col­lab­o­ra­tion with Wave Life Sci­ences that cov­ers re­search, de­vel­op­ment and com­mer­cial­iza­tion. An­ti­sense oligonu­cleotides for ge­net­i­cal­ly de­fined neu­ro­log­i­cal dis­eases is the over­ar­ch­ing theme of the pact, which is bro­ken down in­to two parts: the first in­volves the op­tion to co-de­vel­op and co-com­mer­cial­ize cer­tain pro­grams cur­rent­ly un­der­go­ing clin­i­cal proof of mech­a­nism, while the sec­ond gives Take­da the rights to ex­clu­sive­ly li­cense pre­clin­i­cal pro­grams. Part 1 in­ves­ti­gates ther­a­pies tar­get­ing Hunt­ing­ton’s dis­ease, Lou Gehrih’s dis­ease, fron­totem­po­ral de­men­tia and spin­ocere­bel­lar atax­ia type 3; part 2 deals with oth­er neu­ro­log­i­cal dis­or­ders in­clud­ing Alzheimer’s and Parkin­son’s.

→ Hav­ing formed strate­gic part­ner­ships with Take­da Ven­tures in Japan and UCB Phar­ma in Bel­gium, Ar­ix Bio­science has turned to Chi­na for its lat­est col­lab­o­ra­tion — with Hong Kong-list­ed Fo­s­un In­ter­na­tion­al as its part­ner. The plan is to in­vest in and cre­ate new com­pa­nies to­geth­er on a broad range of new clin­i­cal ther­a­pies, with an em­pha­sis on the grow­ing Chi­nese mar­ket. Ar­ix will pro­vide ac­cess to its group busi­ness­es, pipeline and peo­ple net­work in ex­change for Fo­s­un’s knowl­edge of po­ten­tial in­vest­ment op­por­tu­ni­ties. Al­ready teamed up with Kite in a joint ven­ture, “Fo­s­un’s ex­ten­sive foot­print and net­work in Chi­na will en­hance Ar­ix’s al­ready strong sourc­ing pow­er and pro­vide our Group Busi­ness­es the op­por­tu­ni­ty of de­vel­op­ing a deep re­la­tion­ship with a lead­ing dis­tri­b­u­tion part­ner in Chi­na,” said Ar­ix CEO Joe An­der­son.

Dy­navax $DVAX has bor­rowed $175 mil­lion to launch the new­ly ap­proved Hep­lisav-B. The biotech is get­ting a $100 mil­lion of that now from CRG and has $75 mil­lion avail­able in a sec­ond tranche. The com­pa­ny re­port­ed that it had $192 mil­lion in cash at the end of last year.

→ Cul­li­nan On­col­o­gy, the Cam­bridge, Mass­a­chu­setts-based com­pa­ny that got $150 mil­lion in a Se­ries A back­ing last Oc­to­ber, is team­ing up with Ger­many’s MAB Dis­cov­ery GmbH to de­vel­op an­ti­body ther­a­peu­tics. “We are ex­cit­ed to en­ter in­to this col­lab­o­ra­tion as the MABD de­vel­op­ment en­gine pro­vides us with ac­cess to high­ly dif­fer­en­ti­at­ed mon­o­clon­al an­ti­bod­ies” said Patrick Baeuer­le, Cul­li­nan’s CSO, in a state­ment. “Our first pro­gram is a nov­el ag­o­nis­tic an­ti­body that has the po­ten­tial to be a pil­lar of fu­ture im­muno-on­col­o­gy and stan­dard treat­ments.” The agree­ment does not pro­vide for an up­front pay­ment to MAB Dis­cov­ery. In­stead, MAB Dis­cov­ery re­ceives shares in an un­known amount to Cul­li­nan’s sub­sidiary Cul­li­nan Wit­tels­bach.

Bris­tol My­ers is clean­ing up the post-Cel­gene merg­er pipeline, and they’re sweep­ing out an ex­per­i­men­tal check­point in the process

Back during the lead up to the $74 billion buyout of Celgene, the big biotech’s leadership did a little housecleaning with a major pact it had forged with Jounce. Out went the $2.6 billion deal and a collaboration on ICOS and PD-1.

Celgene, though, also added a $530 million deal — $50 million up front — to get the worldwide rights to JTX-8064, a drug that targets the LILRB2 receptor on macrophages.

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UP­DAT­ED: Leg­end fetch­es $424 mil­lion, emerges as biggest win­ner yet in pan­dem­ic IPO boom as shares soar

Amid a flurry of splashy pandemic IPOs, a J&J-partnered Chinese biotech has emerged with one of the largest public raises in biotech history.

Legend Biotech, the Nanjing-based CAR-T developer, has raised $424 million on NASDAQ. The biotech had originally filed for a still-hefty $350 million, based on a range of $18-$20, but managed to fetch $23 per share, allowing them to well-eclipse the massive raises from companies like Allogene, Juno, Galapagos, though they’ll still fall a few dollars short of Moderna’s record-setting $600 million raise from 2018.

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Mer­ck wins a third FDA nod for an­tibi­ot­ic; Mereo tack­les TIG­IT with $70M raise in hand

Merck — one of the last big pharma bastions in the beleaguered field of antibiotic drug development — on Friday said the FDA had signed off on using its combination drug, Recarbrio, with hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia. The drug could come handy for use in hospitalized patients who are afflicted with Covid-19, who carry a higher risk of contracting secondary bacterial infections. Once SARS-CoV-2, the virus behind Covid-19, infects the airways, it engages the immune system, giving other pathogens free rein to pillage and plunder as they please — the issue is particularly pertinent in patients on ventilators, which in any case are breeding grounds for infectious bacteria.

As it hap­pened: A bid­ding war for an an­tibi­ot­ic mak­er in a mar­ket that has rav­aged its peers

In a bewildering twist to the long-suffering market for antibiotics — there has actually been a bidding war for an antibiotic company: Tetraphase.

It all started back in March, when the maker of Xerava (an FDA approved therapy for complicated intra-abdominal infections) said it had received an offer from AcelRx for an all-stock deal valued at $14.4 million.

The offer was well-timed. Xerava was approved in 2018, four years after Tetraphase posted its first batch of pivotal trial data, and sales were nowhere near where they needed to be in order for the company to keep its head above water.

Drug man­u­fac­tur­ing gi­ant Lon­za taps Roche/phar­ma ‘rein­ven­tion’ vet as its new CEO

Lonza chairman Albert Baehny took his time headhunting a new CEO for the company, making it absolutely clear he wanted a Big Pharma or biotech CEO with a good long track record in the business for the top spot. In the end, he went with the gold standard, turning to Roche’s ranks to recruit Pierre-Alain Ruffieux for the job.

Ruffieux, a member of the pharma leadership team at Roche, spent close to 5 years at the company. But like a small army of manufacturing execs, he gained much of his experience at the other Big Pharma in Basel, remaining at Novartis for 12 years before expanding his horizons.

Covid-19 roundup: Ab­b­Vie jumps in­to Covid-19 an­ti­body hunt; As­traZeneca shoots for 2B dos­es of Ox­ford vac­cine — with $750M from CEPI, Gavi

Another Big Pharma is entering the Covid-19 antibody hunt.

AbbVie has announced a collaboration with the Netherlands’ Utrecht University and Erasmus Medical Center and the Chinese-Dutch biotech Harbour Biomed to develop a neutralizing antibody that can treat Covid-19. The antibody, called 47D11, was discovered by AbbVie’s three partners, and AbbVie will support early preclinical work, while preparing for later preclinical and clinical development. Researchers described the antibody in Nature Communications last month.

Is a pow­er­house Mer­ck team prepar­ing to leap past Roche — and leave Gilead and Bris­tol My­ers be­hind — in the race to TIG­IT dom­i­na­tion?

Roche caused quite a stir at ASCO with its first look at some positive — but not so impressive — data for their combination of Tecentriq with their anti-TIGIT drug tiragolumab. But some analysts believe that Merck is positioned to make a bid — soon — for the lead in the race to a second-wave combo immuno-oncology approach with its own ambitious early-stage program tied to a dominant Keytruda.

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Pfiz­er’s Doug Gior­dano has $500M — and some ad­vice — to of­fer a cer­tain breed of 'break­through' biotech

So let’s say you’re running a cutting-edge, clinical-stage biotech, probably public, but not necessarily so, which could see some big advantages teaming up with some marquee researchers, picking up say $50 million to $75 million dollars in a non-threatening minority equity investment that could take you to the next level.

Doug Giordano might have some thoughts on how that could work out.

The SVP of business development at the pharma giant has helped forge a new fund called the Pfizer Breakthrough Growth Initiative. And he has $500 million of Pfizer’s money to put behind 7 to 10 — or so — biotech stocks that fit that general description.

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Leen Kawas, Athira CEO (Athira)

Can a small biotech suc­cess­ful­ly tack­le an Ever­est climb like Alzheimer’s? Athi­ra has $85M and some in­flu­en­tial back­ers ready to give it a shot

There haven’t been a lot of big venture rounds for biotech companies looking to run a Phase II study in Alzheimer’s.

The field has been a disaster over the past decade. Amyloid didn’t pan out as a target — going down in a litany of Phase III failures — and is now making its last stand at Biogen. Tau is a comer, but when you look around and all you see is destruction, the idea of backing a startup trying to find complex cocktails to swing the course of this devilishly complicated memory-wasting disease would daunt the pluckiest investors.